Home NDC 71335-0468-7 Bupropion Hydrochloride
Product NDC 71335-0468
Requested package NDC 71335-0468-7
11-digit product format 713350468
Labeler code 71335
Product ID 71335-0468_44e8152a-7f02-41e0-b0d4-732339d36b82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075584
Marketing category ANDA
Marketing start 2000-02-07
Marketing end 0000-00-00
Substance BUPROPION HYDROCHLORIDE
Active strength 75 mg/1
Pharmacologic classes Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075584-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 A075584-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71335-0468-7 71335046807 100 TABLET, FILM COATED in 1 BOTTLE (71335-0468-7) 2007-03-08 0000-00-00 No No Current